A recent CNN Health article discussed the regulatory status of a drug intended to reduce the risk of preterm birth. Makena received accelerated approval more than a decade ago, but now FDA leaders will have to decide if the drug should remain on the market. Early trial results for the drug were promising, but a longer study was required to determine if the drug actually reduces the risk of disease and death related to preterm birth. However, after reviewing the larger trial, agency scientists found that the drug wasn’t effective, and showed risk of blood clots.
The director of the Office of New Drugs believes it’s in the best interest of patients for the drug to be removed from the market. The maker of Makena, Covis Pharma, suggested conducting a new trial but believes doctors would be reluctant to refer patients for the trial if the drug is pulled from the market.